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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K923246
Device Name SONACE 2000
Applicant
Medison Co., Ltd.
5319 Randall Pl.
Fremont,  CA  94538
Applicant Contact MARK HAYWARD
Correspondent
Medison Co., Ltd.
5319 Randall Pl.
Fremont,  CA  94538
Correspondent Contact MARK HAYWARD
Regulation Number892.1560
Classification Product Code
IYO  
Date Received07/02/1992
Decision Date 05/20/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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